CTRI Number |
CTRI/2021/12/038785 [Registered on: 21/12/2021] Trial Registered Prospectively |
Last Modified On: |
16/08/2024 |
Post Graduate Thesis |
No |
Type of Trial |
Interventional |
Type of Study
|
Preventive Screening Behavioral |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
Nurse-led intervention on weight reduction among adults with obesity in urban areas of Puducherry |
Scientific Title of Study
|
Effectiveness of nurse-led intervention on weight reduction among adults with obesity in urban areas of Puducherry–An exploratory sequential mixed method. |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr M J Kumari |
Designation |
Professor |
Affiliation |
JIPMER |
Address |
College of Nursing,
JIPMER
College of Nursing,
JIPMER
Pondicherry PONDICHERRY 605006 India |
Phone |
9894595420 |
Fax |
|
Email |
kumari_mj@ymail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr M J Kumari |
Designation |
Professor |
Affiliation |
JIPMER |
Address |
College of Nursing,
JIPMER
College of Nursing,
JIPMER
Pondicherry PONDICHERRY 605006 India |
Phone |
9894595420 |
Fax |
|
Email |
kumari_mj@ymail.com |
|
Details of Contact Person Public Query
|
Name |
VEMBUK |
Designation |
TUTOR |
Affiliation |
JIPMER |
Address |
College of Nursing,
JIPMER
College of Nursing,
JIPMER
Pondicherry PONDICHERRY 605006 India |
Phone |
7845506589 |
Fax |
|
Email |
vkjipmer11@gmail.com |
|
Source of Monetary or Material Support
|
Jawaharlal Institute of Postgraduate Medical Education And Research- Intra mural Research Fund |
|
Primary Sponsor
|
Name |
JIPMER Intra Mural Research Fund |
Address |
JIPMER,Gorimedu,Puducherry |
Type of Sponsor |
Research institution and hospital |
|
Details of Secondary Sponsor
|
|
Countries of Recruitment
|
India |
Sites of Study
|
No of Sites = 1 |
Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
Dr M J Kumari |
Urban areas of Puducherry. |
Mudaliarpet, Odiansalai, Kosapalayam, Murungapakkam Muthialpet, Dubrayapet, Lawspet, Reddiarpalayam , Mettupalayam , Gorimedu, Villianur, Ariankuppam. Pondicherry PONDICHERRY |
9894595420
kumari_mj@ymail.com |
|
Details of Ethics Committee
Modification(s)
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
INSTITUTIONAL ETHICS COMMITTEE FOR NURSING COURSE RESEARCH, JIPMER, PUDUCHERRY |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: E660||Obesity due to excess calories, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
GENERAL CARE SERVICES |
Comparator group will receive the general care services provided by URBAN PRIMARY HEATLH CENTRE |
Intervention |
NURSE-LED INTERVENTION ON WEIGHT REDUCTION |
I. Health education (at common area)
The study participants will be explained on causes of obesity, day to day problems related to obesity, serious health conditions caused by obesity for 15 minutes using pictures on PPT. The study participants will be explained on low carb diet, protein rich diet, low fat diet and fiber rich diet and food to include and avoid by pictures using PPT for 30 minutes. The study participants will be given millet based model menu with 6 breakfasts, 6 lunches, and 6 dinners with adequate vegetables, fruits, protein which fulfils their calorie needs to follow in their day to day life. Model menu plan (individually tailored) will be prepared based on calorie requirement with 10-15% of calorie deficit, physical activity and spending ability on food.The study participants will be explained on walking and home work outs.
II. Motivational strategy during follow up
Participants are asked to maintain food diary and activity diary by own. Calorie intake will be calculated using Diet Cal software and participant will be contacted via mobile to inform about their track. Participants will be interacting with an investigator through phone calls, sms or text messages regarding adherence to intervention, information on weight reduction, clarification of doubts and interact with study participants monthly once. Separate register will be maintained for phone calls. |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
50.00 Year(s) |
Gender |
Both |
Details |
Adults with obesity, aged between 18-50 yrs, all gender,who can speak and write Tamil or English,who access to phone.
|
|
ExclusionCriteria |
Details |
Adults with limitations for physical activities (physical disability and bed ridden), with medications and diseases, which can affect weight loss, currently on weight loss program, bariatric surgery and pregnant, visual and hearing impairments.
• Psychiatric disorders
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
On-site computer system |
Blinding/Masking
|
Open Label |
Primary Outcome
|
Outcome |
TimePoints |
Clinically significant reduction in body weight ≥ 5% from baseline weight among intervention group compared with general care group. |
Baseline assessment- at 1st month
Midline assessment-at 6th month
Endline assessment-at 12th month |
|
Secondary Outcome
|
Outcome |
TimePoints |
Proportion of beneficial effect among nurse-led intervention group
1. Reduction in absolute weight.
2. Reduction in waist circumference.
3. Beneficial changes in FBS, lipid profile.
4. Positive changes on lifestyle (diet, physical activity) modification
|
One year |
|
Target Sample Size
|
Total Sample Size="438" Sample Size from India="438"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="438" |
Phase of Trial
|
N/A |
Date of First Enrollment (India)
|
01/06/2022 |
Date of Study Completion (India) |
29/02/2024 |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
|
Years="3" Months="0" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
1. Krishnasamy V, Jayaram KM, Jayaseelan V.Protocol of randomized controlled trial to evaluate the effectiveness of nurseâ€led intervention on weight reduction among adults with obesity in urban areas of Puducherry. Indian J Endocr Metab 2023;27:154â€60-Indian Journal of Endocrinology and Metabolism
2. Krishnasamy V, Jayaram KM, Jayaseelan V.Fruit- Vegetables Intake And Physicalactivity On The Risk Of Metabolic Syndrome Among Obese Adults In Urban, Puducherry. International Journal Of Scientific Research (Ijsr), Vol. 13, Issue, 2. February 2024.
3.Krishnasamy, Vembu1; Jayaram, Kumari Manjini2; Jayaseelan, Venkatachalam3; Shanmugam, Ramesh4; Sadan, Vathsala5. Effectiveness of nurse-led intervention on weight reduction among adults in urban Puducherry – A randomized controlled pilot trial. Journal of Education and Health Promotion 13(1):210, June 2024. | DOI: 10.4103/jehp.jehp_1411_23
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
This is randomized trial to evaluate the effectiveness of nurse-led intervention on weight reduction among adults with obesity in urban areas of Puducherry. Report of the Pilot Study: The recent increase in type 2 diabetes is likely due to the rising prevalence of overweight and obesity, which heightens the risk of non-communicable diseases. This study aimed to evaluate the effectiveness of nurse-led intervention (NLI) strategies on weight reduction among adults in urban Puducherry. A two-arm, parallel-group, randomized controlled study was conducted with 88 obese adults from Nesavalar colony and Govindanpet between November 2022 and February 2023. Participants were randomized into either the NLI or general care (GC) arm. Interviews were conducted to gather demographic and behavioral risk factor data, and physical and biochemical measurements were taken following standardized procedures. Villages were randomly assigned to either the intervention or control group using Excel. The NLI group received nurse-led interventions, including Surya Namaskar yoga, while the GC group received standard care. At 16 weeks, the NLI arm showed a significant mean weight loss of -2.58 kg, compared to a 0.38 kg gain in the GC arm, with improvements in waist circumference, body mass index, cholesterol profile, and thyroid-stimulating hormone levels. The study demonstrated that nurse-led interventions effectively reduced weight and the risk of non-communicable diseases in urban Puducherry, though a more extensive follow-up plan and additional manpower will be necessary for larger studies. Summary of the Main Study: Participants were interviewed to gather demographic information and assess behavioral risk factors, including diet and physical activity. Physical measurements such as height, weight, waist circumference, and blood pressure were taken following standardized procedures. Biochemical measurements involved blood sample collection after overnight fasting to analyze fasting blood glucose, total cholesterol, and thyroid profile. Villages were randomly assigned to either the intervention or control group using Excel, ensuring equal distribution. No allocation concealment was used since the intervention was applied simultaneously across villages, reducing selection bias. Blinding was not implemented due to the primary investigator’s involvement in both intervention delivery and baseline assessments; however, outcome assessments were conducted by independent nurses who were blinded to group assignments. The intervention group received nurse-led interventions, including sessions on Surya Namaskar (Sun Salutation) yoga, while the control group received standard care. After 12 months, participants’ weight reduction was reassessed and compared with baseline data, and health workers in the control group were subsequently educated using the nurse-led intervention package. COVID-19 precautions were implemented to prevent transmission, particularly in containment zones. |